Class 2 Device Recall Microvent

• Date Initiated by Firm: January 13, 2004
• Date Posted: July 23, 2004
• Recall Status: Terminated on September 01, 2004
• Recall Number: Z-1141-04
• Recall Event ID: 28217
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: Microvent Implant Line
• Code Information: MicroVent Implant Line Part # Description Lot Number Quantity MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0200515 100 MV3H10 Impl, M-V II, HA, 3.7mm, 10mm 0202923 100 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 014962 270 MV3H13 Impl, M-V II, HA, 3.7mm, 13mm 0200428 200 MV3H8 Impl, M-V II, HA, 3.7mm, 8mm 0202162 30 MV4H10 Impl, M-V II, HA, 4.7mm, 10mm 0200516 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 016646 100 MV4H13 Impl, M-V II, HA, 4.7mm, 13mm 0200427 100 MV4H8 Impl, M-V II, HA, 4.7mm, 8mm 0201180 35
• Recalling Firm/ Manufacturer: Zimmer Dental Inc; 1900 Aston Ave; Carlsbad CA 92008-7308
• Manufacturer Reason for Recall: Sterility barrier compromised.
• FDA Determined Cause: Other
• Quantity in Commerce: See Codes
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.